Phase 3 Osteoarthritis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 to 75 years old.
• People who have been diagnosed with knee osteoarthritis in the target knee, based on established medical guidelines.
• People who have tried non-surgical treatments for their knee osteoarthritis (such as weight loss, physical therapy, injections, or pain medications) for at least 3 months without enough relief.
• People whose X-ray shows a moderate level of knee joint damage in the target knee (a specific rating of grade 2 or 3 on a standard scale), as confirmed by an independent radiologist.
• People whose MRI shows significant cartilage damage in the target knee of a specific size and severity, as confirmed by an independent radiologist (confirm with trial site).
• People with a Body Mass Index (BMI) of 35 or below (a measure of body weight relative to height).
• People whose pain level in the target knee falls within a specific moderate-to-severe range on a standard pain scale at the screening visit.
• People whose pain level in the other (non-target) knee is relatively low on a standard pain scale at the screening visit.
• People whose knee function and pain scores in the target knee fall within specific ranges on a standard questionnaire at the screening visit.
• People who are willing to avoid other treatments in the target knee for the duration of the study.
• People who are willing to stop using pain medications during the study, except for paracetamol (acetaminophen) for breakthrough pain, certain short-term anti-inflammatory medications after surgery (as directed), and pain relief medications prescribed after surgery — and who are willing to stop all pain medications at least 48 hours before each scheduled study assessment visit.
• People with very high blood pressure (stage 3 hypertension) whose blood pressure is brought under control before any surgical procedure in the trial.
• People whose standard blood test results are within normal limits, or whose results are considered not medically concerning by the investigating doctor.
• Women who could become pregnant must agree to use effective contraception throughout the study.
• People who are able and willing to follow the required rehabilitation programme after the procedure.
• People who are able to understand and follow all study requirements.
• People who voluntarily agree to take part and sign a written consent form.
• People whose pain score and knee function score at the baseline assessment visit (just before the procedure) also fall within specific required ranges on standard scales (confirm with trial site).
• People whose cartilage damage in the target knee, as assessed by the treating doctor during the surgical procedure, is confirmed to be within the required size and severity range.

Who may not be able to join:

• People who have received certain knee injections — such as hyaluronic acid, platelet-rich plasma (PRP), bone marrow concentrate, long-acting steroid, or an investigational drug — in either knee within 3 months before signing consent.
• People whose MRI shows a specific pattern of bone damage (grade 3 bone marrow lesion) in certain areas of the target knee, as assessed by an independent radiologist.
• People whose X-ray shows either very mild (grade 0 or 1) or very severe (grade 4) joint damage in the target knee.
• People whose X-ray shows very severe (grade 4) joint damage in the other (non-target) knee.
• People whose knee alignment is significantly off (angled 6 degrees or more inward or outward) in either knee.
• People with significant ligament instability in the target knee that is at or above a certain severity level, or that would require surgery on its own.
• People with complete loss of meniscal tissue, meniscal root tears, or severe meniscal displacement in the target knee, as assessed by an independent radiologist.
• People with a specific type of cartilage damage on both sides of the knee joint that meets certain size or depth criteria, as assessed by an independent radiologist.
• People who have had surgery on the target knee within 6 months before signing consent, or who have had radiation therapy to the target knee.
• People with chronic inflammatory joint conditions such as rheumatoid arthritis, gout, or fibromyalgia.
• People with certain bone conditions affecting the target knee, such as bone death (avascular necrosis), bone cysts above a certain size, bone tumours, or stress fractures, as identified by imaging.
• People with joint infections, bone infections, soft tissue tumours, or bone marrow infiltration in the target knee, as identified by imaging.
• People with certain metabolic or genetic diseases affecting bone or connective tissue, such as Paget's disease, acromegaly, haemochromatosis, Wilson's disease, or genetic collagen disorders.
• People with blood vessel or nerve disorders affecting the legs (note: varicose veins alone are not a reason for exclusion).
• People with certain autoimmune conditions, including multiple sclerosis, lupus, rheumatoid arthritis, Sjögren's syndrome, myasthenia gravis, dermatomyositis, Addison's disease, or inflammatory bowel disease (note: coeliac disease is not a reason for exclusion).
• People with documented systemic diseases including HIV, hepatitis, syphilis, or blood clotting disorders such as haemophilia or thrombocytopenia (note: a deep vein thrombosis that occurred 5 or more years ago is not a reason for exclusion).
• People currently taking blood-thinning medications such as warfarin, apixaban, rivaroxaban, or clopidogrel (note: low-dose 81mg aspirin is not a reason for exclusion).
• People with poorly controlled diabetes (HbA1c above 8%).
• People with an active infection currently being treated with antibiotics given by injection or intravenous drip.
• People who have taken certain immune-suppressing medications within 6 months before signing consent.
• People who have received chemotherapy within the 12 months before signing consent.
• People who have previously received other allogeneic (donor-derived) stem cell therapy.
• People who have had certain prior cartilage repair procedures (such as MACI, ACI, OATS, or similar) in the target knee, or who have a partial knee replacement in the target knee (note: revision of a prior microfracture procedure may be allowed under specific conditions — confirm with trial site).
• People who have had certain other invasive knee treatments in the target knee, such as subchondroplasty, nerve ablation, artery embolisation, or implanted knee devices.
• People with a known allergy to hyaluronan (a substance used in some knee treatments).
• People who are currently pregnant or breastfeeding.
• People with a history of psychotic illness or epilepsy.
• People with a known history of substance or alcohol misuse in the past 3 years.
• People who are unable or unwilling to have MRI scans, or for whom MRI is medically unsuitable.
• People who are currently involved in legal proceedings related to workers' compensation, personal injury, or disability claims.
• People considered unsuitable for the trial by the principal investigator for any other reason.
• People found at the time of surgery to have certain additional findings — such as meniscal root tears, kissing cartilage lesions of a certain size or depth, bone or joint infections, bone tumours, or prior cartilage repair procedures — that were not identified before surgery (confirm with trial site).
• People confirmed to be pregnant by a urine or blood test immediately before surgery.

Important: Always verify eligibility with the trial site directly before applying.